Biomerix's Assure soft tissue repair mesh has obtained CE mark approval to reconstruct hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
Assure is made of three distinct layers in which the first layer comprises of the Biomerix Biomaterial which is a proprietary, biointegrative synthetic polyurethane tissue scaffold designed to support tissue repair and regeneration similar to that of the body’s extracellular matrix.
The second layer is a knitted polypropylene monofilament mesh which provides mechanical support for a strong, durable and flexible repair.
The third layer comprises a resorbable lactide caprolactone copolymer film which is designed to minimize tissue attachment to the device in case of direct contact with the viscera.
Biomerix president and CEO Kenneth Hayes said the device incorporates the properties of a biologic tissue scaffold with the best properties of a synthetic biomaterial in terms of its strength and durability.
"Assure is already available in the US after receiving a 510(k) clearance from the US Food and Drug Administration (FDA) in May 2010," Hayes said.